Hamlet BioPharma (HAMLET) Life Science Summit 2025 summary

Key announcements and clinical progress

• Received FDA feedback supporting pivotal development path for Alpha1H, a first-in-class neoadjuvant for low-risk non-muscle invasive bladder cancer.

• FDA guidance provided on primary and secondary endpoints, central pathology review, and protocol finalization.

• Plans to incorporate FDA recommendations, finalize protocol, and initiate enrollment at first study sites early next year.

• Phase III quality material ready for release; evaluating expedited FDA program designations.

• Three positive clinical trials completed, including non-inferiority in recurrent urinary tract infection and promising results in bladder pain syndrome.

Pipeline and innovation highlights

• Pipeline includes Alpha1H and other Hamlet molecules with broad anti-cancer activity and low toxicity.

• Data supports potential for use in colon, skin, and brain tumors, with animal data available for all.

• Non-antibiotic approaches to infection show efficacy against both sensitive and resistant bacteria in animal models.

• Patent portfolio includes about 150 cases, with ongoing discovery and development.

Organizational and leadership updates

• Announcement of new board member Henrik Sundin, experienced in financial markets and business development.

• Jakob Testad, long-time financial coordinator, to assume CEO role, with Catharina Svanborg moving to chairman of the board.

• Organization described as virtual but supported by national experts in legal, finance, partnering, production, and regulatory affairs.